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FDAnews Drug Daily Bulletin

Data Integrity Concerns Lead to Warning Letter for Czech Facility

Nov. 2, 2016

Interpharm Praha has received an FDA warning letter that cites data integrity issues at a facility in the Czech Republic.

The inspection found Interpharm’s quality system does not ensure the adequacy and integrity of data to support the safety, effectiveness and quality of drugs made at the plant. In addition, the quality control unit did not have basic controls to prevent changes to laboratory data.

During the inspection, investigators reviewed an audit trail from the Empower-2 system that stored 8,906 entries. Of these, well over half indicated some form of data deletion or manipulation, including at least 1,441 instances of deleted results, at least 3,643 instances of manual integration, and at least 194 instances of altered running sample sets.

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